NASHVILLE, Tenn. - Compounding pharmacies like the one
responsible for the deadly outbreak of fungal meningitis last year have
refused access to inspectors.
U.S. Food and Drug Administration Commissioner Margaret Hamburg told The Tennessean (http://tnne.ws/12SNi6s) that the FDA had to get court orders to enter and inspect two pharmacies.
"It
is striking and very concerning that even in the follow-up to all that
has happened with the meningitis outbreak ... we are still having
problems getting into some of the facilities in order to inspect them,"
Hamburg said.
Injectable
steroid medicine made by the New England Compounding Center in
Massachusetts was responsible for an outbreak that has sickened 733
people across the nation with 53 deaths. The medicine was supposed to be
sterile, but it was found to be contaminated with mold.
The outbreak was first identified in Tennessee, where 152 people were sickened with 14 deaths.
Since
the outbreak, the FDA has stepped up inspections of compounding
pharmacies, which sometimes operate like drug manufacturers but with
less regulation.
Howard
Sklamberg, the head of compliance for the FDA's center for drug
evaluation and research, said the two pharmacies that have refused
access to inspectors are Wedgewood Village Pharmacy Inc. in New Jersey
and Olympia Compounding Pharmacy in Florida.
"You
have to get a judge's order. You have to then get the marshals to
accompany our investigators to an inspection, which is not the normal
way we do business," Sklamberg said.
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